CINCINNATI (June 19, 2024) – The Christ Hospital Health Network is now screening patients for participation in the ALT-FLOW II clinical trial. This trial is designed to evaluate the Edwards APTURE transcatheter shunt, an investigational device, intended to alleviate symptoms of shortness of breath and to improve functional capacity.
The study will evaluate the safety, performance and effectiveness of this device in trial participants with symptomatic heart failure and preserved left ventricular ejection fraction, also known as HFpEF, which is a particularly difficult subgroup of patients to treat. The ALT-FLOW II trial design will ensure any benefit seen in trial participants that receive the device can be attributed to the device and are not due to placebo effect. The investigational APTURE shunt device is designed to decompress elevated left atrial pressures that occur with physical exertion by “shunting” blood from the left atrium to the coronary sinus and right atrium with the intent to relieve symptoms like shortness of breath.
"Our participation in the ALT-FLOW II trial provides our patients with HFpEF, who are symptomatic despite receiving optimal medical therapy, an additional therapeutic option,” said Dean Kereiakes, MD, Chairman of The Christ Hospital Heart and Vascular Institute and National Co-Principal Investigator for the ALT-FLOW II trial. “We are collecting data to help us better understand this increasingly common condition.”
Heart failure is a chronic condition that occurs when the heart muscle is not functioning as well as it should. Heart failure with mildly-reduced or preserved ejection fraction (HFmrEF and HFpEF respectively) occurs when the heart muscle becomes stiff and does not relax and fill properly causing pressure in the heart to rise particularly with physical exertion. Over time this may result in symptoms such as shortness of breath, fatigue, swelling in the legs and ankles, and difficulty exercising.
“In order to offer the latest technology, treatment and care for our heart failure patients, clinical trials like the ALT-FLOW II are invaluable for The Christ Hospital Health Network to remain a destination for heart care,” said Santiago Garcia, MD, Principal Investigator of the ALT-FLOW II trial at The Christ Hospital Health Network. “We need to better understand the role of device therapy in heart failure, a condition that remains a leading cause of morbidity and mortality despite advances in medical therapy.”
For additional trial details go to clinicaltrials.gov and search for NCT05686317. Those interested in participating in this trial should contact The Christ Hospital Health Network to learn more by calling (513) 585-1777.
About The Christ Hospital Health Network
The Christ Hospital Health Network consists of an acute care hospital located in Mt. Auburn, a remote hospital location in Liberty Township, five ambulatory outpatient centers and dozens of medical offices throughout the region. For more than 130 years, The Christ Hospital has provided compassionate care to those it serves. Made up for more than 1,300 physicians and more than 6,500 team members, our mission is to improve the health of our community by providing exceptional outcomes in an affordable way. The Network was recognized by U.S. News & World Report as the #1 hospital in the Cincinnati Region and named to Newsweek’s World’s Best Hospitals list in 2024. It is also a Press Ganey Guardian of Excellence Award recipient, which recognizes top-performing healthcare organizations that achieve the 95th percentile or above of performance in patient experience.